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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Baxter
QuintilesIMS
Citi
Boehringer Ingelheim
Daiichi Sankyo
Cerilliant
Moodys
Covington
Express Scripts

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205917

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NDA 205917 describes PARICALCITOL, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma Inc, Dr Reddys Labs Ltd, Eci Pharms Llc, Marksans Pharma, Rising Pharms Inc, Teva Pharms Usa, Accord Hlthcare, Akorn, Amneal Pharms Co, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc, and is included in sixteen NDAs. It is available from seventeen suppliers. Additional details are available on the PARICALCITOL profile page.

The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 205917
Tradename:PARICALCITOL
Applicant:Hikma Pharms
Ingredient:paricalcitol
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205917
Ingredient-typeCholecalciferol
Suppliers and Packaging for NDA: 205917
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205917 NDA West-Ward Pharmaceutical Corp 0143-9596 0143-9596-25 25 VIAL, MULTI-DOSE in 1 CARTON (0143-9596-25) > 2 mL in 1 VIAL, MULTI-DOSE (0143-9596-01)
PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205917 NDA West-Ward Pharmaceutical Corp 0143-9624 0143-9624-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9624-25) > 1 mL in 1 VIAL, SINGLE-DOSE (0143-9624-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.002MG/ML (0.002MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.005MG/ML (0.005MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.01MG/2ML (0.005MG/ML)
Approval Date:Nov 18, 2014TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
Harvard Business School
AstraZeneca
Express Scripts
Deloitte
Teva
Citi
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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